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| | '''Coronavirus treatments''' are being discussed without any conclusive proof yet of effectiveness. | | '''Coronavirus treatments''' are being discussed without any conclusive proof yet of effectiveness. |
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| − | The [[FDA]] sharply impedes the development of new medications in the [[United States]], while [[communist]] [[China]] allows more freedom in rapidly developing and using new treatments. But the FDA is not authorized to make decisions about the practice of medicine, and thus it is generally allowed for a physician to use an old medication for a new purpose if it has been previously approved without limitation by the FDA. This is known as "off-label" use of a drug.
| + | French researchers using a small sample size found a high cure rate by using a combination of hydroxychloroquine (a treatment for malaria) and azithromycin (an antibiotic):<ref>Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of |
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| − | "From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient."<ref>https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label</ref>
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| − | As explained by the website for the [[National Institutes of Health]]:<ref>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/</ref>
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| − | {{cquote|Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine ....}}
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| − | French researchers using a small sample size found a high cure rate by using a combination of hydroxychloroquine (a treatment for malaria and azithromycin (an antibiotic):<ref>Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of | |
| | COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of | | COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of |
| | Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949 [https://www.mediterranee-infection.com/wp-content/uploads/2020/03/Hydroxychloroquine_final_DOI_IJAA.pdf]</ref> | | Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949 [https://www.mediterranee-infection.com/wp-content/uploads/2020/03/Hydroxychloroquine_final_DOI_IJAA.pdf]</ref> |
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| | Twenty cases were treated in this study and showed a significant reduction of the viral carriage at D6-post inclusion compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. Azithromycin added to hydroxychloroquine was significantly more efficient for virus elimination.}} | | Twenty cases were treated in this study and showed a significant reduction of the viral carriage at D6-post inclusion compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. Azithromycin added to hydroxychloroquine was significantly more efficient for virus elimination.}} |
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| − | An article in ''Nature'' suggests the potential for off-label use of hydroxychloroquine, which was used long ago for [[malaria]] and was first synthesized in 1946, to treat [[coronavirus]] (SARS-CoV-2):<ref name="Nature">https://www.nature.com/articles/s41421-020-0156-0</ref> | + | An article in ''Nature'' also suggests the potential for off-label use of hydroxychloroquine, which was used long ago for [[malaria]] and was first synthesized in 1946, to treat [[coronavirus]] (SARS-CoV-2):<ref name="Nature">https://www.nature.com/articles/s41421-020-0156-0</ref> |
| | {{cquote|[O]ur results show that HCQ [Hydroxychloroquine] can efficiently inhibit SARS-CoV-2 infection in vitro. In combination with its anti-inflammatory function, we predict that the drug has a good potential to combat the disease.}} | | {{cquote|[O]ur results show that HCQ [Hydroxychloroquine] can efficiently inhibit SARS-CoV-2 infection in vitro. In combination with its anti-inflammatory function, we predict that the drug has a good potential to combat the disease.}} |
| | Communist China has been developing treatment guidelines, now in their sixth edition, faster than the [[United States]] has. The Guidelines for the Diagnosis and Treatment of COVID-19 (6th Ed.), which is published by the National Health Commission of communist [[China]], lists chloroquine (CQ) phosphate as a potentially even better drug than HCQ due to a lower cost, more potent effect, and wider availability.<ref name="Nature"/> | | Communist China has been developing treatment guidelines, now in their sixth edition, faster than the [[United States]] has. The Guidelines for the Diagnosis and Treatment of COVID-19 (6th Ed.), which is published by the National Health Commission of communist [[China]], lists chloroquine (CQ) phosphate as a potentially even better drug than HCQ due to a lower cost, more potent effect, and wider availability.<ref name="Nature"/> |
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| | Azithromycin is reportedly effective in reducing the viral load, and in combating lung infections which are associated with COVID-19.<ref>https://www.businessinsider.com/malaria-pill-chloroquine-tested-as-coronavirus-treatment-2020-3</ref> | | Azithromycin is reportedly effective in reducing the viral load, and in combating lung infections which are associated with COVID-19.<ref>https://www.businessinsider.com/malaria-pill-chloroquine-tested-as-coronavirus-treatment-2020-3</ref> |
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| | + | == Off-Label Use and the FDA == |
| | + | |
| | + | The [[FDA]] sharply impedes the development of new medications in the [[United States]], while [[communist]] [[China]] allows more freedom in rapidly developing and using new treatments. But the FDA is not authorized to make decisions about the practice of medicine, and thus it is generally allowed for a physician to use an old medication for a new purpose if it has been previously approved without limitation by the FDA. This is known as "off-label" use of a drug. |
| | + | |
| | + | "From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient."<ref>https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label</ref> |
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| | + | As explained by the website for the [[National Institutes of Health]]:<ref>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/</ref> |
| | + | {{cquote|Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine ....}} |
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| | ==References== | | ==References== |